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AXINON® LDL-p Test System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210801
510(k) Type
Traditional
Applicant
numares AG
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
7/19/2023
Days to Decision
854 days
Submission Type
Summary

AXINON® LDL-p Test System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210801
510(k) Type
Traditional
Applicant
numares AG
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
7/19/2023
Days to Decision
854 days
Submission Type
Summary